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PMA P120017S019

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S019
Product code
DTB
Decision date
2019-09-27
Classification
Permanent Pacemaker Electrode
Generic name
permanent pacemaker Electrode
Approval order statement
Transfer of receiving and incoming inspection activities from Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC) Villalba, MPROC Juncos, and the Federal Express/Third Party Logistics facility in Guaynabo, Puerto Rico.

Current openFDA PMA Record#

Device
Myocardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P120017
Supplement
S019
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2019-09-27
Decision code
OK30
Date received
2019-09-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer of receiving and incoming inspection activities from Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC) Villalba, MPROC Juncos, and the Federal Express/Third Party Logistics facility in Guaynabo, Puerto Rico.